POS1256 RISK FACTORS FOR SHORT-TERM ADVERSE EVENT IN PATIENTS WITH IMMUNE-MEDIATED INFLAMMATORY DISEASES
Authors: L. Kummer, L. Wieske, E. Stalman, K. Van Dam, L. Boekel, G. Wolbink, A. Volkers, M. Steenhuis, N. Verstegen, T. Rispens, A. Ten Brinke, Z. Van Kempen, S. Tas, M. Van Ham, T. Kuijpers, F. Eftimov
Journal: Annals of the Rheumatic Diseases (2022)

Background Many countries are promoting booster SARS-CoV-2 vaccination campaigns as the COVID-19 pandemic continues. Incremental short-term adverse events after two SARS-CoV-2 vaccinations have been reported in healthy individuals. 1,2 However, data on incremental short-term adverse events in patients with various immune-mediated inflammatory diseases (IMIDs) after repeated SARS-CoV-2 vaccination is scarce. Objectives We report risk factors for short-term adverse events in IMID patients after SARS-CoV-2 vaccination. Methods Self-reported daily questionnaires on adverse events in the first seven days after SARS-CoV-2 vaccination were obtained from individuals participating in an ongoing prospective multi-arm multicenter cohort study on SARS-CoV-2 vaccination in patients with various IMIDs in the Netherlands (T2B! immunity after SARS-CoV-2). Clinically relevant adverse events were defined as systemic adverse advents lasting longer than two days or hindering daily activities. Adjusted relative risks for developing clinically relevant adverse events were calculated using a logistic mixed-effects model. Results Data of 2081 patients and 178 healthy controls were obtained. Inflammatory bowel disease (N:480), Multiple sclerosis (N:343) and Rheumatoid arthritis (N:266) were the largest disease groups. Adjusted relative risks for relevant adverse events are presented in Figure 1. Third vaccination was not associated with increased risk on adverse events when compared to a second vaccination (aRR: 0.93 95% CI: 0.84-1.02). Patients with IMIDs were at increased risk for developing adverse events after vaccination when compared to controls (aRR: 1.16 95% CI: 1.01-1.34). Female sex (aRR 1.43 95% CI: 1.32-1.56), age below 50 (aRR 1.14 95% CI: 1.06-1.23) and a preceding SARS-CoV-2 infection (aRR: 1.14 95% CI: 1.01-1.29) were also associated with increased risk of adverse events following vaccination. Allergic reactions and hospital admission were uncommon (0.67% and 0.19% respectively); 7.4% and 6.8% of patients reported adverse events impacting daily life on day seven after second and third vaccination, respectively. Data on increase in disease activity of the IMID following vaccination are currently being investigated. Figure 1. Risk factors for adverse events after SARS-CoV-2 vaccination in patients with immune-mediated inflammatory disease Conclusion A third SARS-CoV-2 vaccination was not associated with an increased risk on short-term clinically relevant adverse events when compared to a second vaccination. Although patients with IMIDs may be slightly more at risk to develop adverse events after SARS-CoV-2 vaccination, most adverse events were transient and disappeared within seven days. This message should reassure IMID patients who are hesitant on booster vaccination. Data on potential IMID flare-ups after vaccination will follow. References [1]Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med . 2020;383(27):2603-2615. doi:10.1056/NEJMoa2034577 [2]Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403-416. doi:10.1056/NEJMoa2035389 Acknowledgements We would like to thank ZonMw (The Netherlands Organization for Health Research and Development, grant 10430072010007) for the funding of the study and the T2B partners, including the patient groups and Health Holland for the support in this study. Also, we would like to thank E.P. Moll van Charante, J.A Bogaards and R.A. Scholten for their guidance in the data safety monitoring board. Disclosure of Interests Laura Kummer: None declared, Luuk Wieske: None declared, Eileen Stalman: None declared, Koos van Dam: None declared, Laura Boekel: None declared, Gertjan Wolbink Grant/research support from: GW reported a grant from ZonMW (Netherlands Organization for Healthcare research and Innovation) for COVID research in patients with auto-immune diseases., Adriaan Volkers: None declared, Maurice Steenhuis: None declared, Niels Verstegen: None declared, Theo Rispens: None declared, Anja ten Brinke: None declared, Zoé van Kempen: None declared, Sander Tas: None declared, Marieke van Ham: None declared, Taco Kuijpers Grant/research support from: TW reported a grant from ZonMW (Netherlands Organization for Healthcare research and Innovation) for COVID research in patients with auto-immune diseases., Filip Eftimov Grant/research support from: FE reported a grant from ZonMW (Netherlands Organization for Healthcare research and Innovation) for COVID research in patients with auto-immune diseases.